Ask the Expert

Edition: October 2005 - Vol 13 Number 10
Article#: 2230
Author: Repertoire

Q. My accounts are complaining that they have to run two daily controls with their CLIA-waived test kits. Is this true?

– Ohio distributor rep

A. All your customers have to do for waived tests is “follow the manufacturer’s instructions,” so if the package insert says that two daily controls are required, then by CLIA law, customers must run two controls on each day of testing. To put things in perspective though, you can casually mention that only 2 percent of CLIA-waived labs will ever be inspected. In fact, in my experience, only about 2 percent of CLIA-waived testers have ever read their package inserts!

Proof that alcohol hand rinses work

Q. I have a big account that won’t switch to alcohol hand rinses because the head doctor doesn’t believe they work and won’t agree to supply them. Where can I get documentation to prove that they do work?

– Wisconsin distributor rep

A. This doctor probably learned in medical school that antimicrobial soap was the only way to go. He’s probably still wearing the same ties he wore back in the ’60s, too. There is an overwhelming number of studies proving that alcohol-based hand cleansers work better than handwashing to kill bugs. Also, employees who never wash their hands will actually use alcohol-based products because they don’t destroy their skin, and they don’t have to throw their backs out leaning over a sink for 45 seconds.

So, refer this fellow to the latest U.S. Public Health Guidelines from the Centers for Disease Control and Prevention, where alcohol rinses are recommended, at Oops, you might have to print these out for him, since he probably doesn’t believe in computers either! Or, contact your Metrex rep and get a free copy of an 8-page OSHA Watch newsletter (written by yours truly) that extols the value of alcohol rinses.

Selling screening tests to HMOs?

Q. Cigna, one of our local HMOs, mailed fecal occult blood tests directly to patients to screen for colon cancer. I’m wondering who sold them these tests. In other words, do you think it’s worth my while to call on insurance plans and suggest they screen patients for bone density, kidney disease, diabetes or high cholesterol?

– Late bird who lost a big worm in Florida

A. Cigna spent $40,000 mailing 40,000 members over age 50 the Insure Fecal Immunochemical test. Even being mathematically challenged, I figure that someone gave Cigna a real deal on these FOBT tests.

Once patients open the test and smear a little bit of “sample” on it, Cigna members mail the tests back to Quest Diagnostics lab for interpretation. Although patients are encouraged to “share” their test results with their doctors, physicians are obviously being left out of the loop. Why? They’re probably not screening patients as often as they should, despite screening guidelines from specialty societies and the U.S. government. In fact, a recent ADVAMed report says critical diagnostic screening tests for diabetes, cardiac disease and some types of cancer were so underused in 2004 that about 34,000 avoidable deaths occurred.

So, managed care plans are going directly to patients to get results. Cigna figures that one member with colorectal cancer costs them about $37,000; they’re hoping to save money by diagnosing several pre-cancerous or early cancer cases.

This is a pilot program, and Cigna and Quest intend to go nationwide if they don’t have the same problem that doctors do with FOBT tests: getting those darn patients to return them.

Also this month, more than 300,000 CIGNA HealthCare members across the country will be delighted to find in their mailboxes a postcard encouraging them to get one of the five colorectal cancer screenings recommended by the American Cancer Society. Although they are instructed to go to their doctors for these tests, less than half actually will.

To answer your question, selling to managed care plans is a high-level sale that requires close partnership with a manufacturer, since prices must be carefully negotiated to compensate for the huge volume. On the other hand, if physicians would approach their health plans and tell them they want to offer a screening program in their community, any managed care plan would bend over backwards to help them market it by sending flyers or posting ads in the local newspapers. They will also reimburse physicians for each test performed. Physicians might not become millionaires doing this, but they sure would attract a lot of new patients.

Moderate complexity CLIA fees

Q. I have an account that is currently moderately complex. How much will the CLIA fees be to renew the license at about six CBCs per day?

– Ohio manufacturer’s rep

A. About $1,000, since each CBC counts as five tests under CLIA. Remember, when breaking this to the customer, that CLIA fees are assessed every two years, so CLIA fees are really $500 per year, in this case. Since this account does about 1,500 CBCs per year, the CLIA fees are about $.30 per test. Also, when they grasp their heart and begin to pant heavily from sticker shock, remind them that the cost per test is about $2.50 and the reimbursement is about $11.

CLIA fees vary about +/- 15 percent by state, so have the account call the state CLIA office (find the telephone numbers at, if they want to know the exact amount. Use the chart below for a rough estimate for all your non-waived accounts.

CLIA Fees Big news for vaccines

Q. What are the requirements for flu shots this year? In other words, where will the hottest markets be?

– New York distributor

A. The hot item this flu season is vaccinations for nursing home patients against influenza and pneumonia (or they risk losing Medicare and Medicaid eligibility). There are almost 2 million residents in approximately 18,000 nursing homes, so this represents a huge selling opportunity.

Last year, only 65 percent of nursing home residents received flu shots; Uncle Sam wants to raise that figure to 90 percent this year. To sweeten the deal, Medicare officials say they would pay nursing homes $18 for each vaccination on top of the cost of the actual dose. Expect sales of the pneumonia vaccine to soar too, since only 38 percent of elderly patients received them last year.

Last year, elderly patients got first priority for flu shots, but this was just a rump rocket in disguise, because Chiron Corp. lost its license and couldn’t deliver 48 million doses (half the anticipated supply). Despite initial confusion, long lines and people just giving up on the vaccine, the season ended with a surplus of unused vaccines.

This year, Chiron is fixing its problems and is expected to join sanofi pasteur and GlaxoSmithKline in the U.S. market. Finally, Med Immune Inc. makes the nasal spray vaccine (and prices have come down, I hear).

Last year, Uncle Sam urged all healthcare workers to get the flu vaccine from their employers, but compliance varied. A hospital in Washington State was sued by the nurse’s union for trying to force the nurses to get the vaccine last year, while many doctors’ offices and nursing homes didn’t even offer it to their employees. Maybe some nice managed care company will mail it to workers’ homes (Read story above if you don’t get this)!